Recalls / Class III

Class IIID-603-2013

Product

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

Affected lot / code info

Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)

Why it was recalled

Subpotent; 24 month stability test station

Recalling firm

Firm

Hi-Tech Pharmacal Co., Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

369 Bayview Ave, Amityville, New York 11701-2801

Distribution

Quantity

lot 608917: 7764 bottles; lot 608204: 7476 bottles

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2013-04-30

FDA classified

2013-06-14

Posted by FDA

2013-06-26

Terminated

2016-05-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-603-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.